MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP SYPHILIS (SYPH) ASSAY; SYPHILIS ASSAY

Model Number N/A

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2014

Event Type  malfunction  

Event Description

False negative advia centaur xp syphilis (syph) results were obtained for a patient sample during validation.The patient sample was tested on the immulite 2000 and the result was reactive.The patient sample was tested on the fta-abs blood test (confirmatory test).The test resulted in positive for igg and negative for igm.It is unknown if patient treatment was altered or prescribed.There was no report of adverse health consequences due to the discordant advia centaur xp syphilis results.

Manufacturer Narrative

The customer declined service as there were no issues with the other assays on the system.The cause for the discordant syphilis (syph) results is unknown.The instrument is performing within specifications.No further evaluation of the device is required.The ifu states in the limitations section: "a nonreactive test result does not exclude the possibility of exposure to or infection with syphilis.T.Pallidum antibodies may be undetectable in some stages of the infection and in some clinical conditions.".

• Brand Name: ADVIA CENTAUR XP SYPHILIS (SYPH) ASSAY
• Type of Device: SYPHILIS ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 5086604603
• MDR Report Key: 4369798
• MDR Text Key: 5267045
• Report Number: 1219913-2014-00311
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K112343
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2015
• Device Model Number: N/A
• Device Catalogue Number: 10492493
• Device Lot Number: 017 AND 018
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2014
• Initial Date FDA Received: 12/30/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/27/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1